The goal of the Atopic Dermatitis and Vaccinia Network (ADVN) is to research methods for preventing atopic dermatitis (AD) subjects from contracting eczema vaccinatum (EV), a potentially fatal complication of smallpox vaccinations. A critical host defense defect uncovered in subjects with AD is their apparent relative lack of expression of antimicrobial peptides (AMPs), specifically cathelicidins, under inflammatory conditions. AMPs are important effectors and triggers in the innate immune system, and the lack of expression of these peptides in AD patients could be a key component in their susceptibility to EV. The main Vitamin D3 study will examine whether or not the administration of oral Vitamin D3 over 21 days will change the AMP expression in the skin and saliva of AD subjects and healthy controls. Many new avenues of research are also being explored in this subject population and require initial exploratory data to be collected to assess their potential. As an addition to the Antimicrobial Response to Oral Vitamin D protocol, this substudy protocol will provide further control information on psoriatic responses to oral vitamin D; information on bacterial colonization in AD, non-AD, and psoriatic subjects; and assess tape stripping as a noninvasive method for the measurement of cathelicidin skin expression.

instance of dataset

1 - Includes updates to the original data submission short of completeness.

available with registration

To examine the effect of oral administration of Vitamin D3 on AMP (hCAP18/LL-37, HBD3) expression in psoriatic subjects' skin (change in expression over 21 days in AMP mRNA in lesional skin compared to change in non-lesional skin in subjects who receive oral Vitamin D3) as compared to change in AMP expression in lesional and non-lesional skin of psoriatic subjects who receive the Vitamin D3 placebo. To examine the effect of oral administration of Vitamin D3 on TH2 cytokine expression (IL-13, IL-4) in psoriatic subjects' skin as compared to expression in lesional and non-lesional skin of subjects who receive the Vitamin D3 placebo. To compare these Vitamin D3 effects on AMP (hCAP18/LL-37, HBD3) expression and TH2 cytokine expression (IL-13, IL-4) in psoriatic subjects to the effects in ADn and non-AD subjects. To measure with-in subject variability across study time in AMP (hCAP18/LL-37, HBD3) expression and TH2 cytokine expression (IL-13, IL-4) in psoriatic subjects in lesional and non-lesional skin, using subjects who receive the Vitamin D3 placebo. To measure the effect of oral administration of Vitamin D3 over 21 days on AMP (hCAP18/LL-37, HBD3) expression in psoriatics subjects' saliva as compared to psoriatic subjects who receive the Vitamin D3 placebo and as compared to AD and non-AD subjects. To examine the effect of oral adminstration of Vitamin D3 over 21 days on serum total IgE and RAST testing in psoriatic subjects blood as compared to blood from psoriatic subjects who receive the Vitamin D3 placebo. To examine the effect of the oral administration of Vitamin D3 over 21 days on PASI score from psoriatic subjects as compared to from psoriatic subjects who receive the Vitamin D3 placebo. To compare the baseline bacterial colony counts among AD, non-AD, and psoriatic subjects. To measure the effect of oral administration Vitamin D3 on bacterial colong counts in AD, non-AD, and psoriatic subjects, as compared to Vitamin D3 placebo controls. To measure within-subject variability across study time in bacterial colony counts in AD, non-AD, and psoriatic subjects. To determine whether antimicrobial peptide levels can be accurately measured from tape stripping (using skin punch biopsies as the gold standard) of lesional and non-lesional skin from AD, non-AD, and psoriatic subjects. To examine the effect of oral administration of Vitamin D3 over 21 days on superficial bacterial flora as assessed by genomic analysis in AD, non-AD, and psoriatic subjects.

registration required

Psoriais, Atopic Dermatitis

Richard Gallo

University of California at San Diego

principal investigator

Antimicrobial Response to Oral Vitamin D3 in Patients with Psoriasis

62

Atopic Dermatitis & Vaccinia Network (ADVN) Clinical Studies Consortium

Difference in change in expression of antimicrobial peptides (hCAP18/LL-37, HBD3) from baseline to study day 21 in psoriatic subjects' lesional skin biopsies compared to change in expression of antimicrobial peptides from baseline to study day 21 in their non-lesional skin biopsies. Expression of antimicrobial peptides (hCAP18/LL-37, HBD3) at baseline and study day 21 in psoriatic subjects' saliva and lesional and non-lesional skin biopsies. Bacterial colony counts (colony forming units) at baseline and study day 21 in AD, non-AD, and psoriatic subjects. Change in bacterial colony counts (colony forming units) from baseline to study day 21 in AD and non-AD, and psoriatic subjects. Expresion of antimicrobial peptides (hCAP18/LL-37, HBD3) at baseline and study day 21 in psoriatic subjects' lesional and non-lesional skin tape strips. Change in expression of TH2 cytokines IL-13 and IL-4 from baseline and study day 21 in psoriatic subjects' lesional and non-lesional skin biopsies. Change in expression of serum total IgE and RAST from baseline and study day 21 in psoriatic subjects' serum. Change in PASI score from baseline and study day 21 in psoriatic subjects. Profile of bacteria present in lesional and non-lesional skin swabs at baseline and study day 21 in AD, non-AD, and psoriatic subjects.

AD+ Vitamin D3: AD receiving Vitamin D3 4000 IU

AD+ Placebo: AD receiving Placebo

Healthy controls Vitamin D3: Non-atopic receiving Vitamin D3 4000 IU

Healthy controls Placebo: Non-atopic receiving Placebo

Psoriasis Vitamin D3: Psoriatic receiving Vitamin D3 4000 IU

Psoriasis Placebo: Psoriatic receiving Placebo

Unassigned Subjects: Subjects not assigned to a cohort

Atopic Dermatitis (AD) is a skin disorder in which people often have swelling and skin infection. People with this disease cannot receive the smallpox vaccine because it could cause them to have a fatal reaction known as eczema vaccinatum (EV). AD subjects have a lack of antimicrobial peptides (AMPs) under inflammatory conditions. This is a substudy to the ADVN Vitamin D3 study (ADVN CATH 03).

10.21430/M3U5ABTPCJ

2009-01-07

ImmPort

SCR:012804